FDA 483 - Jae S. Cho, M.D - December 31, 2025

An FDA inspection of Jae S. Cho, M.D. at University Hospitals Cleveland Medical Center in Cleveland, OH, revealed significant deficiencies in clinical study conduct. The firm failed to adhere to protocol for reporting serious adverse events, with multiple instances of delayed entry into the electronic database. Additionally, the study utilized informed consent documents that were not approved by the IRB and were improperly altered by the study coordinator.